GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(360)
• Posters(77)
• Presentations(193)
• Papers(90)

• Building Mechanistic IVIVC

  Lukacova, Viera

• Modeling Complex Particle Interactions in Dry Powder Inhaler

  Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran

• Critical Roles for Locally Acting PBPK in Regulatory Decisions

  Lionberger, Robert

• CFD Lung Models for Drug Delivery

  Lin, Ching-Long

• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use – Guidance Implementation in Q1/Q2 Assessment

  Li, Xinran

• IVPT Data Challenges in the Real World

  Lehman, Paul

• Diffusion Cell Apparatus: Considerations for Design and Use II

  Lee, Luke

• Ophthalmic Drug Products: Leveraging M&S Approaches to Perform Inter-Species Predictions and Support Drug Product Development and Approval

  Le Merdy, Maxime

• A Microdialysis Approach to Assess Dermal Pharmacokinetics of Topical Dermatological Drug Product

  Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia

• Case Study: Predicting Regional Lung Deposition of Pharmaceutical Aerosols with CFD

  Longest, Worth; Dutta, Rabijit